[Federal Register: January 16, 2009 (Volume 74, Number 11)]
[Notices]
[Page 3059-3060]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16ja09-105]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0371 (formerly Docket No. 2007D-0125)]
Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document entitled ``Guidance for Industry:
Evidence-Based Review System for the Scientific Evaluation of Health
Claims.'' This guidance outlines the agency's approach to the review of
the scientific evidence for health claims that meet the significant
scientific agreement standard (SSA) and qualified health claims.
Elsewhere in this issue of the Federal Register, FDA is announcing the
withdrawal of the guidance documents entitled ``Guidance for Industry
and FDA: Interim Evidence-Based Ranking System for Scientific Data''
and ``Guidance for Industry: Significant Scientific Agreement in the
Review of Health Claims for Conventional Foods and Dietary
Supplements.''
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Nutrition, Labeling, and Dietary Supplements, Center for
Food Safety and Applied Nutrition, (HFS-830), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to assist that office in processing
your requests.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments on the
guidance to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Paula R. Trumbo, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1191.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 9, 2007 (72 FR 37246), FDA
announced the availability of a draft guidance entitled ``Guidance for
Industry: Evidence-Based Review System for the Scientific Evaluation of
Health Claims.'' The agency considered received comments as it
finalized this guidance. The primary purpose of this guidance is to
provide a description of the scientific evaluation process that FDA
uses in determining the strength of the relationship of a substance to
decreasing the risk of a disease or health-related condition.
FDA is issuing this guidance document as a level 1 guidance
consistent with FDA's good guidance practices regulation (21 CFR
10.115). This guidance represents the agency's current thinking on the
evaluation of scientific evidence for health claims. It does not create
or confer any rights for or on any person and does not operate to bind
FDA or the public. An alternate approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and
[[Page 3060]]
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 101.14 and 101.70 have
been approved under OMB control no. 0910-0381.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
http://www.cfsan.fda.gov/guidance.html.
V. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site address, but FDA is not responsible for
any subsequent changes to this Web site after this document publishes
in the Federal Register.)
1. American Cancer Society, Cancer Facts and Figures, 2004.
2. The Alpha-Tocopherol, Beta Carotene Cancer Prevention Study
Group, ``The Effect of Vitamin E and Beta Carotene on the Incidence
of Lung Cancer and Other Cancers in Male Smokers, New England
Journal of Medicine, 330:1029-1035, 1994.
3. Barton S., ``Which Clinical Studies Provide the Best
Evidence? The Best RCT Still Trumps the Best Observational Study,''
British Medical Journal, 321:255-256, 2000.
4. Cade, J., R. Thompson, V. Burley, et al., ``Development,
Validation and Utilization of Food-Frequency Questionnaires--A
Review, Public Health Nutrition, 5:567-587, 2002.
5. Federal Judicial Center, Reference Manual on Scientific
Evidence, 2d ed., 2000.
6. Flegal K.M., ``Evaluating Epidemiological Evidence of the
Effects of Food and Nutrient Exposures,'' American Journal of
Clinical Nutrition, 69:1339S-1344S, 1999.
7. Greer N., G. Mosser, G. Logan, et al., ``A Practical Approach
to Evidence Grading,'' Joint Commission Journal on Quality
Improvements, 26:700-712, 2000.
8. Hill A.B., ``The Environment and Disease: Association or
Causation?,'' Proceedings of the Royal Society of Medicine, 58:295-
300, 1965.
9. Hord N.G. and J.I. Fenton, ``Context is Everything: Mining
the Normal and Preneoplastic Microenvironment for Insights Into the
Diet and Cancer Risk Conundrum,'' Molecular Nutrition and Food
Research, 51:100-106, 2007.
10. IOM, Institute of Medicine, ``Dietary Supplements: A
Framework for Evaluating Safety,'' National Academies Press,
Washington, DC, 2005.
11. Kraemer H.C., K.K. Lowe, D.J. Kupfer, To Your Health: How to
Understand What Research Tell Us About Risk, Oxford University
Press, 2005.
12. Kris-Etherton, P.M. and J. Dietschy, ``Design Criteria for
Studies Examining Individual Fatty Acid Effects on Cardiovascular
Disease Risk Factors: Human and Animal Studies,'' American Journal
of Clinical Nutrition, 1590S-1596S, 1997.
13. Lichtenstein, A.H. and R.M. Russell, ``Essential Nutrients:
Food or Supplements?'' Journal of American Medical Association,
294:351-358, 2005.
14. Milner J.A., ``Diet and Cancer: Facts and Controversies,''
Nutrition and Cancer, 56: 216-224, 2006.
15. National Cancer Institute, Dictionary of Cancer Terms,
http://www.cancer.gov/dictionary.
16. National Research Council, ``Diet and Health: Implications
for Reducing Chronic Disease Risk,'' National Academy Press,
Washington, DC, 1989.
17. Omenn, G.S., G.E. Goodman, M.D. Thornquist, et al.,
``Effects of a Combination of Beta Carotene and Vitamin A on Lung
Cancer and Cardiovascular Disease,'' New England Journal of
Medicine, 334:1150-1155, 1996.
18. Peto, R., R. Doll, J.D. Buckley, et al., ``Can Dietary Beta-
Carotene Materially Reduce Human Cancer Rates?,'' Nature, 290:201-
208, 1981.
19. Sempos C.T., K. Liu, N.D. Earnst, ``Food and Nutrient
Exposures: What to Consider When Evaluating Epidemiologic Data,''
American Journal of Clinical Nutrition, 69:1330S-1338S, 1999.
20. Torun B., ``Protein-Energy Malnutrition,'' In: Modern
Nutrition in Health and Disease, Williams and Williams, New York,
2006.
21. Spilker, B., Guide to Clinical Studies, Raven Press, New
York, 1991.
22. Subar, A., et al., ``Comparative Validation of the Block,
Willett, and National Cancer Institute Food Frequency
Questionnaires,'' American Journal of Epidemiology, 154:1089-1099,
2001.
23. Szklo M. and F.J. Nieto, Epidemiology Beyond the Basics,
Aspen Publishing, 2000.
24. Willett, W.C., ``Overview of Nutritional Epidemiology,''
Nutritional Epidemiology, Oxford University Press, Oxford, 1990.
25. Willett, W.C., ``Issues in Analysis and Presentation of
Dietary Data,'' In Nutritional Epidemiology, 2d ed., Oxford
University Press, Oxford, 1998.
26. Wilson, E.B., ``An Introduction to Scientific Research,''
General Publishing Co., Toronto, 1990.
Dated: January 13, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-957 Filed 1-15-09; 8:45 am]
BILLING CODE 4160-01-S